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| Clinical Data Manager - Aortic |
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The Aortic Business Unit of W.L. Gore & Associates is looking for an experienced clinical data manager responsible for driving data management activities from study development through close-out within Clinical Affairs.
Key Responsibilities:
· Work within Aortic Clinical Affairs Team to design Case Report Forms and databases for individual studies
· Develop a Data Management Plan for individual studies including database structure, data entry guidelines, data validity checks, data conventions, query procedures and data validation
· Supervise and assist with the process of data entry, editing and validation for individual studies
· Assist in the transfer of data across platforms for other users both internally and externally to Clinical Affairs
· Participate with the development of standards for data management procedures and database structure across studies
· Create test scripts and perform User Acceptance Testing to support study database testing
· Coordinate all data output for Medical internal review, Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) meetings, Annual Reports, publication support and regulatory efforts
· Maintain an overall knowledge of applicable regulations, regulatory guidance documents, industry standards, and new technologies
Participate in Clinical Affairs Process Improvement initiative
· Bachelor's degree
· Experience in a Clinical Data Manager role in medical device/pharmaceutical industry or equivalent
· Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, Lotus Notes)
· Strong organizational skills, flexibility, and ability to multi-task
· Strong verbal and written communication skills
EEO/AA Employer (applies to all positions located in the U.S.)
Additional Information:
For further information regarding Gore, visit our website at www.gore.com
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Company:
W. L. Gore & Associates |
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Location:
Flagstaff, AZ 86001 |
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Status:
Full Time, Employee |
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Job Category:
Marketing/Product |
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Company:
W. L. Gore & Associates |
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Reference Code:
091268 |
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